Probiotic effects of Bacillus subtilis DSM21097 supplementation on patients after recurrent Clostridioides difficile infection and healthy adults

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients:
1. Age = 18 years
2. Patient has had a first episode of CDI* and at least one recurrence
3. Patient is scheduled for or currently taking Fidaxomicin, but treatment will be finished upon study entry
4. Written informed consent provided prior to inclusion

Healthy subjects:
1. Age = 18 years
2. Written informed consent provided prior to inclusion
3. Healthy participant, as determined by screening assessment and Principal Investigator's judgment

Exclusion Criteria

Patients:
1. Patient with any social or logistical condition, which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted for follow-up assessments
2. Planned fecal microbiota transfer (FMT) at inclusion into the study
3. Patient with a high risk for antibiotic treatment at study inclusion (except for Fidaxomicin)
4. Severely immunocompromised patients, defined as:
a. Current or foreseeable neutropenia within the next 14d, defined as <500 Neutrophils/µl
b. Scheduled for allogeneic SCT or having received allogeneic SCT within 100d
c. Active Graft versus Host Disease requiring immunosuppressive treatment
d. Patients with <200 CD4 T-cells/µl
e. Use of corticosteroids at a mean dose of 0.3mg/kg/d of prednisone equivalent for >3 weeks
f. Treatment with other recognized T-cell immunosuppressants, such as cyclosporine, TNF-alpha blockers, specific monoclonal antibodies (e.g. alemtuzumab), MTX or nucleoside analogues during the last 90 days
g. Inherited severe immunodeficiency (e.g.chronic granuloumatous disease or severe combined immunodeficiency)
5. Patient requiring intensive care treatment at inclusion
6. Patient has one of the following comorbidities: inflammatory bowel disease (ulcerative colitis or Crohn’s disease), irritable bowel syndrome
7. Prolonged Fidaxomicin therapy immediately prior to inclusion (> 28 days)
8. Patient is allergic to one of the study treatment components: glycerin, gelatin, sunflower lecithin

Healthy subjects:
1. Participant has a significant history or manifestation of any metabolic, immunological, neurological, cardiovascular, gastrointestinal or other relevant disorder
2. Participant has any kind of chronic disease
3. Expected or frequent changes in standard medication (contraceptives, thyroid hormones and similar hormonal substitution is allowed, when verified by the Investigator or designee)
4. Participant is allergic to one of the study treatment components: glycerin, gelatin, inulin, sunflower lecithin, citric acid, pyridoxine hydrochloride, orange oil, cyanocobalamin, steviol glycosides

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the extent of changes in the microbiota composition of study participants following a 30-days probiotic intervention using 16S rRNA and fungal ITS next-generation sequencing (NGS)

Secondary Outcome Measures